Insomnia ChronicNCT06604208
Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"
A study testing Binaural Beats in people with Insomnia Chronic, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn if binaural beat works to treat chronic insomnia in adults. It will also learn about the safety of binaural beat. The main questions it aims to answer are: What medical problems do participants have when using binaural beat? Researchers will compare binaural beat to a… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- Binaural Beats
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Dec 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: No restrictions, Age: Between 20 and 75 years.
- Meets the criteria for insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5):
- Difficulty sleeping and insomnia occurring at least 3 nights per week.
- Insomnia and sleep difficulties persisting for at least 3 months.
- The participant has signed the informed consent form.
Who cannot join
- Individuals who are unable to complete the consent form, undergo testing, and attend regular follow-up visits as required by the study.
- Individuals with severe physical illnesses or post-surgical conditions, such as heart disease or metabolic disorders.
- Individuals with severe psychiatric disorders, including schizophrenia, major depressive disorder, severe anxiety disorder, bipolar disorder, dementia, or substance use disorders; or severe neurological conditions, such as stroke or epilepsy.
- Individuals with other severe sleep disorders, such as severe sleep apnea.
- Individuals who are unable to maintain a stable medication dosage during the trial period, particularly with ongoing treatments.
- Patients deemed unsuitable for participation in the trial by the principal investigator.
- Patients who are unable to adhere to sleep hygiene practices or who cannot refrain from using electronic devices before bedtime.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Yi-Min Fang, MD, 886931776313, butterlion721@gmail.com
About this study
Official title: Double-blind, Randomized, Placebo-controlled Trial to Explore the Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"
The goal of this clinical trial is to learn if binaural beat works to treat chronic insomnia in adults. It will also learn about the safety of binaural beat. The main questions it aims to answer are:
What medical problems do participants have when using binaural beat? Researchers will compare binaural beat to a placebo to see if binaural beat works to treat chronic insomnia.
Participants will:
Using binaural beat or a placebo every day for 2 weeks Keep a diary and actigraphy of their insomnia symptoms Visit the clinic after 2 weeks testing for checkups and tests
Read the detailed description
As the pace of society accelerates, people are under increasing mental stress, which can lead to emotional instability and even insomnia. Insomnia is a common sleep disorder characterized by difficulty falling asleep, poor sleep quality, and early awakening. Studies have shown that chronic insomnia is closely related to diseases such as hypertension and type 2 diabetes and can lead to impaired daytime functioning and mood disorders. The prevalence of insomnia is high, affecting about 10% of the global population. In Taiwan, the prevalence of chronic insomnia is 11.3%, with higher rates observed in women and the elderly. However, many insomnia patients receive only medication, despite the potential side effects of long-term use of sleeping pills. Therefore, exploring the effectiveness of non-pharmacological treatments for insomnia is crucial. In recent years, various non-invasive and non-pharmacological therapies such as mindfulness therapy, acupressure therapy, and acupuncture therapy have gained attention. Overall, the demand for research and treatment of insomnia is increasing.
Additionally, some emerging therapies such as Schumann wave therapy and binaural beat therapy are being explored in research. The former has been shown to improve sleep quality, while the latter has shown potential for enhancing sleep. Binaural beats play a significant role in sleep medicine. This auditory stimulation involves hearing slightly different frequencies in each ear, influencing the brain through the brainstem and reticular activating system to create a new frequency, thereby improving sleep quality. Research indicates that dynamic binaural beats (DBB) can effectively shorten sleep latency and reduce heart rate variability, helping to enhance sleep quality. Furthermore, the application of binaural beats has expanded to the field of insomnia treatment, aiming to help insomnia patients improve sleep quality and increase safety. These research findings suggest that binaural beats may be a non-invasive, effective, non-pharmacological treatment option for sleep support.
The binaural beat device is a health product that is not classified as a medical device. It functions similar to a music box, providing different frequencies through physiological and psychological induction. This process offers binaural beat information to the Reticular Activating System (RAS) for potential changes in consciousness. The binaural beat frequencies are designed to match the brainwave frequency of light sleep, specifically 3.4 Hz (θ waves), with a base frequency of 440 Hz. The device uses three types of background music-piano music, light music, and string music-as experimental materials.
The binaural beat device offers three modes, allowing users to select different modes based on their comfort and listening preferences. This study requires that the binaural beats are listened to for at least 30 minutes. The device has a built-in app for continuous playback, so users can connect the power and listen throughout the night.
- Conditions
- Insomnia Chronic
- Being tested
- Binaural Beats, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural BeatsDevice
The binaural beat device is a health product that is not classified as a medical device. It functions similarly to a music box, providing different frequencies through physiological and psychological induction. This process offers binaural beat information to the Reticular Activating System (RAS) for potential changes in consciousness. The binaural beat frequencies are designed to match the brainwave frequency of light sleep, specifically 3.4 Hz (θ waves), with a base frequency of 440 Hz. The device uses three types of background music-piano music, light music, and string music-as experimental materials.
The binaural beat device offers three modes, allowing users to select different modes based on their comfort and listening preferences. This study requires that the binaural beats be listened to for at least 30 minutes. The device has a built-in app for continuous playback, so users can connect the power and listen throughout the night.
PlaceboDevice
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Binaural Beats | Experimental | Not described Receives: Device: Binaural Beats |
| Placebo | Sham comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a standardized questionnaire designed to assess sleep quality and patterns over a one-month period. The PSQI has a scoring range from 0 to 21, with higher scores indicating worse sleep quality. The questionnaire is divided into seven components, each addressing different aspects of sleep, such as sleep duration, disturbances, and daytime dysfunction. The sum of these component scores gives the overall PSQI score.
Measured: baseline, week3, week 7
Actigraphy
Actigraphy is a non-invasive method used to monitor and assess sleep patterns and circadian rhythms. It involves wearing a small, wristwatch-like device called an actigraph, which measures movement over extended periods, typically one week or longer. By analyzing the data collected, researchers or clinicians can estimate sleep duration, sleep onset, wake times, and periods of restlessness. Actigraphy is particularly useful for studying sleep in naturalistic settings, providing an objective measure of sleep-wake cycles without requiring the individual to stay in a sleep lab. It is often used to assess sleep disorders, such as insomnia or circadian rhythm disturbances, and can be an essential tool for both clinical evaluations and sleep research.
Measured: baseline, week1-2
Secondary outcomes (5)
Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire used to assess an individual\'s general level of daytime sleepiness. The ESS asks respondents to rate their likelihood of falling asleep in eight different situations that are commonly encountered in daily life. The scale ranges from 0 to 24, with higher scores indicating greater levels of daytime sleepiness. Higher scores on the ESS reflect a worse outcome in terms of sleep health.
Measured: baseline, week3, week 7
Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a widely used self-report questionnaire designed to assess the severity of depressive symptoms in individuals. The BDI consists of 21 items, each corresponding to a specific symptom of depression, such as sadness, pessimism, or loss of interest. Respondents rate each item on a scale from 0 to 3, resulting in a total score that ranges from 0 to 63. Higher scores on the BDI indicate more severe depressive symptoms, with specific thresholds used to categorize the severity of depression (e.g., minimal, mild, moderate, or severe). Therefore, higher scores represent a worse outcome, signaling more intense depression.
Measured: baseline, week3, week 7
Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) is a self-report questionnaire used to assess the severity of anxiety symptoms in individuals. The BAI consists of 21 items, each describing a common symptom of anxiety, such as nervousness, dizziness, or fear of losing control. Respondents rate how much they have been bothered by each symptom over the past week on a scale from 0 to 3. The total score ranges from 0 to 63, with higher scores indicating more severe anxiety. Specific score ranges help categorize the level of anxiety (e.g., minimal, mild, moderate, or severe), making higher scores reflective of a worse outcome in terms of anxiety severity.
Measured: baseline, week3, week 7
Short Form (36) Health Survey (SF-36)
The Short Form (36) Health Survey (SF-36) is a widely used questionnaire designed to assess overall health-related quality of life across multiple dimensions. It includes 36 items that measure eight key health concepts: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health perceptions. The SF-36 generates scores for each of these domains, as well as two summary measures: physical and mental health. Scores for each domain and summary measure range from 0 to 100, with higher scores indicating better health and quality of life. Therefore, higher scores on the SF-36 represent a better outcome.
Measured: baseline, week3, week 7
Sleep diary
A Sleep Diary is a self-reported tool used to track sleep patterns and behaviors over a period of time, typically one to two weeks. It includes daily entries where individuals record various aspects of their sleep, such as bedtime, wake time, sleep onset latency, number and duration of awakenings, and overall sleep quality. The data collected is used to identify sleep patterns, irregularities, and potential sleep disorders, making it a valuable resource for both clinical assessments and personal sleep management.
Measured: baseline, week1-3, week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Dec 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Shu Huang, MD, PhD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604208
- Sponsor's protocol ID
- 202401052B0
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agarwal SD, Landon BE. Patterns in Outpatient Benzodiazepine Prescribing in the United States. JAMA Netw Open. 2019 Jan 4;2(1):e187399. doi: 10.1001/jamanetworkopen.2018.7399.
PubMed 30681713Belisheva NK, Popov AN, Petukhova NV, Pavlova LP, Osipov KS, Tkachenko SE, Varanova TI. [Qualitative and quantitative assessment of exposure to geomagnetic field variations on the functional status of the human brain]. Biofizika. 1995 Sep-Oct;40(5):1005-12. Russian.
PubMed 8555283Buscemi N, Vandermeer B, Friesen C, Bialy L, Tubman M, Ospina M, Klassen TP, Witmans M. The efficacy and safety of drug treatments for chronic insomnia in adults: a meta-analysis of RCTs. J Gen Intern Med. 2007 Sep;22(9):1335-50. doi: 10.1007/s11606-007-0251-z. Epub 2007 Jul 10.
PubMed 17619935Colzato LS, Barone H, Sellaro R, Hommel B. More attentional focusing through binaural beats: evidence from the global-local task. Psychol Res. 2017 Jan;81(1):271-277. doi: 10.1007/s00426-015-0727-0. Epub 2015 Nov 26.
PubMed 26612201Galvez G, Recuero M, Canuet L, Del-Pozo F. Short-Term Effects of Binaural Beats on EEG Power, Functional Connectivity, Cognition, Gait and Anxiety in Parkinson's Disease. Int J Neural Syst. 2018 Jun;28(5):1750055. doi: 10.1142/S0129065717500551. Epub 2017 Nov 13.
PubMed 29297265Wahbeh H, Calabrese C, Zwickey H. Binaural beat technology in humans: a pilot study to assess psychologic and physiologic effects. J Altern Complement Med. 2007 Jan-Feb;13(1):25-32. doi: 10.1089/acm.2006.6196.
PubMed 17309374Zampi DD. Efficacy of Theta Binaural Beats for the Treatment of Chronic Pain. Altern Ther Health Med. 2016 Jan-Feb;22(1):32-8.
PubMed 26773319
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Trial to Explore the Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"
- ClinicalTrials.gov ID
- NCT06604208
- Acronym / sponsor ID
- 202401052B0
- Conditions
- Insomnia Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if binaural beat works to treat chronic insomnia in adults. It will also learn about the safety of binaural beat. The main questions it aims to answer are:
What medical problems do participants have when using binaural beat? Researchers will compare binaural beat to a placebo to see if binaural beat works to treat chronic insomnia.
Participants will:
Using binaural beat or a placebo every day for 2 weeks Keep a diary and actigraphy of their insomnia symptoms Visit the clinic after 2 weeks testing for checkups and tests
Detailed description
As the pace of society accelerates, people are under increasing mental stress, which can lead to emotional instability and even insomnia. Insomnia is a common sleep disorder characterized by difficulty falling asleep, poor sleep quality, and early awakening. Studies have shown that chronic insomnia is closely related to diseases such as hypertension and type 2 diabetes and can lead to impaired daytime functioning and mood disorders. The prevalence of insomnia is high, affecting about 10% of the global population. In Taiwan, the prevalence of chronic insomnia is 11.3%, with higher rates observed in women and the elderly. However, many insomnia patients receive only medication, despite the potential side effects of long-term use of sleeping pills. Therefore, exploring the effectiveness of non-pharmacological treatments for insomnia is crucial. In recent years, various non-invasive and non-pharmacological therapies such as mindfulness therapy, acupressure therapy, and acupuncture therapy have gained attention. Overall, the demand for research and treatment of insomnia is increasing.
Additionally, some emerging therapies such as Schumann wave therapy and binaural beat therapy are being explored in research. The former has been shown to improve sleep quality, while the latter has shown potential for enhancing sleep. Binaural beats play a significant role in sleep medicine. This auditory stimulation involves hearing slightly different frequencies in each ear, influencing the brain through the brainstem and reticular activating system to create a new frequency, thereby improving sleep quality. Research indicates that dynamic binaural beats (DBB) can effectively shorten sleep latency and reduce heart rate variability, helping to enhance sleep quality. Furthermore, the application of binaural beats has expanded to the field of insomnia treatment, aiming to help insomnia patients improve sleep quality and increase safety. These research findings suggest that binaural beats may be a non-invasive, effective, non-pharmacological treatment option for sleep support.
The binaural beat device is a health product that is not classified as a medical device. It functions similar to a music box, providing different frequencies through physiological and psychological induction. This process offers binaural beat information to the Reticular Activating System (RAS) for potential changes in consciousness. The binaural beat frequencies are designed to match the brainwave frequency of light sleep, specifically 3.4 Hz (θ waves), with a base frequency of 440 Hz. The device uses three types of background music-piano music, light music, and string music-as experimental materials.
The binaural beat device offers three modes, allowing users to select different modes based on their comfort and listening preferences. This study requires that the binaural beats are listened to for at least 30 minutes. The device has a built-in app for continuous playback, so users can connect the power and listen throughout the night.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binaural Beats | Experimental | Device: Binaural Beats |
| Placebo | Sham comparator | Device: Placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gender: No restrictions, Age: Between 20 and 75 years.
- Meets the criteria for insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5):
- The participant has signed the informed consent form.
Key exclusion criteria (7 listed)
- Individuals who are unable to complete the consent form, undergo testing, and attend regular follow-up visits as required by the study.
- Individuals with severe physical illnesses or post-surgical conditions, such as heart disease or metabolic disorders.
- Individuals with severe psychiatric disorders, including schizophrenia, major depressive disorder, severe anxiety disorder, bipolar disorder, dementia, or substance use disorders; or severe neurological conditions, such as stroke or epilepsy.
- Individuals with other severe sleep disorders, such as severe sleep apnea.
- Individuals who are unable to maintain a stable medication dosage during the trial period, particularly with ongoing treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binaural BeatsThe binaural beat device is a health product that is not classified as a medical device. It functions similarly to a music box, providing different frequencies through physiological and psychological induction. This process offers binaural beat information to the Reticular Activating System (RAS) for potential changes in consciousness. The binaural beat frequencies are designed to match the brainwave frequency of light sleep, specifically 3.4 Hz (θ waves), with a base frequency of 440 Hz. The device uses three types of background music-piano music, light music, and string music-as experimental materials. The binaural beat device offers three modes, allowing users to select different modes based on their comfort and listening preferences. This study requires that the binaural beats be listened to for at least 30 minutes. The device has a built-in app for continuous playback, so users can connect the power and listen throughout the night. | Device | Binaural Beats |
| PlaceboPlacebo | Device | Placebo |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline, week3, week 7
The Pittsburgh Sleep Quality Index (PSQI) is a standardized questionnaire designed to assess sleep quality and patterns over a one-month period. The PSQI has a scoring range from 0 to 21, with higher scores indicating worse sleep quality. The questionnaire is divided into seven components, each addressing different aspects of sleep, such as sleep duration, disturbances, and daytime dysfunction. The sum of these component scores gives the overall PSQI score.
Actigraphy
Time frame: baseline, week1-2
Actigraphy is a non-invasive method used to monitor and assess sleep patterns and circadian rhythms. It involves wearing a small, wristwatch-like device called an actigraph, which measures movement over extended periods, typically one week or longer. By analyzing the data collected, researchers or clinicians can estimate sleep duration, sleep onset, wake times, and periods of restlessness. Actigraphy is particularly useful for studying sleep in naturalistic settings, providing an objective measure of sleep-wake cycles without requiring the individual to stay in a sleep lab. It is often used to assess sleep disorders, such as insomnia or circadian rhythm disturbances, and can be an essential tool for both clinical evaluations and sleep research.
5 secondary outcomes
Epworth Sleepiness Scale (ESS)
Time frame: baseline, week3, week 7
Beck Depression Inventory (BDI)
Time frame: baseline, week3, week 7
Beck Anxiety Inventory (BAI)
Time frame: baseline, week3, week 7
Short Form (36) Health Survey (SF-36)
Time frame: baseline, week3, week 7
Sleep diary
Time frame: baseline, week1-3, week 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Background: PubMed 30681713Agarwal SD, Landon BE. Patterns in Outpatient Benzodiazepine Prescribing in the United States. JAMA Netw Open. 2019 Jan 4;2(1):e187399. doi: 10.1001/jamanetworkopen.2018.7399.
- Background: PubMed 8555283Belisheva NK, Popov AN, Petukhova NV, Pavlova LP, Osipov KS, Tkachenko SE, Varanova TI. [Qualitative and quantitative assessment of exposure to geomagnetic field variations on the functional status of the human brain]. Biofizika. 1995 Sep-Oct;40(5):1005-12. Russian.
- Background: PubMed 17619935Buscemi N, Vandermeer B, Friesen C, Bialy L, Tubman M, Ospina M, Klassen TP, Witmans M. The efficacy and safety of drug treatments for chronic insomnia in adults: a meta-analysis of RCTs. J Gen Intern Med. 2007 Sep;22(9):1335-50. doi: 10.1007/s11606-007-0251-z. Epub 2007 Jul 10.
- Background: PubMed 26612201Colzato LS, Barone H, Sellaro R, Hommel B. More attentional focusing through binaural beats: evidence from the global-local task. Psychol Res. 2017 Jan;81(1):271-277. doi: 10.1007/s00426-015-0727-0. Epub 2015 Nov 26.
- Background: PubMed 29297265Galvez G, Recuero M, Canuet L, Del-Pozo F. Short-Term Effects of Binaural Beats on EEG Power, Functional Connectivity, Cognition, Gait and Anxiety in Parkinson's Disease. Int J Neural Syst. 2018 Jun;28(5):1750055. doi: 10.1142/S0129065717500551. Epub 2017 Nov 13.
- Background: PubMed 17309374Wahbeh H, Calabrese C, Zwickey H. Binaural beat technology in humans: a pilot study to assess psychologic and physiologic effects. J Altern Complement Med. 2007 Jan-Feb;13(1):25-32. doi: 10.1089/acm.2006.6196.
- Background: PubMed 26773319Zampi DD. Efficacy of Theta Binaural Beats for the Treatment of Chronic Pain. Altern Ther Health Med. 2016 Jan-Feb;22(1):32-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Shu Huang, MD, PhD study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural Beats in people with Insomnia Chronic, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Min Fang, MD (+886931776313, butterlion721@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: baseline, week3, week 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06604208, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.